Ignite Creation Date:
2024-05-06 @ 4:33 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05027373
Status:
UNKNOWN
Last Update Posted:
2021-08-30
First Post:
2021-08-17
Brief Title:
Safety Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection
Sponsor:
Sunshine Guojian Pharmaceutical Shanghai Co Ltd
Organization:
Sunshine Guojian Pharmaceutical Shanghai Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel Trial of Safety Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody by Single Subcutaneous Injection in Healthy Subjects
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is Safety Tolerability and Pharmacokinetic of Recombinant anti-IL-1β Humanized Monoclonal Antibody injection in Healthy Subjects Pharmacokinetics Pharmacodynamics and Anti-drug antibody ADA data will be collected Drug safety tolerability and immunogenicity for healthy subjects will be evaluated
Detailed Description:
This study is a randomized double-blind placebo-controlled parallel trial of safety tolerability and pharmacokinetic of Recombinant anti-IL-1β Humanized Monoclonal Antibody by single subcutaneous injection with five different doses in healthy subjects There are 5 groups as follows 003mgkg S1 10mgkg S2 30mgkg S3 60mgkg S4 and 100mgkg S5 and 2 subjects were included in the S1 group both received study drugs 8 subjects were included in each of the S2 S5 groups of which 6 received study drugs and 2 received placebo In each group two subjects were sentinels 1 received the study drug and 1 placebo Pharmacokinetics Pharmacodynamics and Anti-drug antibody ADA data will be collected Drug safety tolerability and immunogenicity for healthy subjects will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None